Ex Parte Fine et al

Patent Trial and Appeal Board

Dec 1, 2017

13017768 (P.T.A.B. Dec. 1, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/017,768 01/31/2011 David H. Fine 16250.0022 7301
27890 7590 12/05/2017
STEPTOE & JOHNSON LLP
1330 CONNECTICUT AVENUE, N.W.
WASHINGTON, DC 20036
EXAMINER
SUL, DOUGLAS YOUNG
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
12/05/2017 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
hfox @ steptoe. com
ipdocketing @ steptoe.com
lfielding @ steptoe.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DAVID H. FINE, RYAN DENTON, GREGORY VASQUEZ, and
BRYAN JOHNSON
Appeal 2017-011502
Application 13/017,768
Technology Center 3700
Before ANNETTE R. REIMERS, THOMAS F. SMEGAL, and
GORDON D. KINDER, Administrative Patent Judges.
REIMERS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE1
David H. Fine et al.2 (Appellants) appeal under 35 U.S.C. § 134(a)
from the Examiner’s decision to reject under 35 U.S.C. § 103(a) claims 1—4,
1 The Examiner objected to independent claims 1 and 21 due to
“informalities.” See Final Act. 2 (dated Mar. 7, 2016). Appellants submitted
an Amendment After Final Action proposing to amend claims 1 and 21 to
correct the informalities. See Amendment After Final Action, 1—4 (filed June
7, 2016). In the Advisory Action, the Examiner states that “the proposed
amendment(s)” “will be entered.” Adv. Act. Summary Sheet PTOL—303
(dated July 26, 2016). Accordingly, the Examiner’s objection to the claims is
moot.
2 We are informed that the real party in interest is GeNO LLC. Br. 3 (filed
Mar. 7, 2017.)
Appeal 2017-011502
Application 13/017,768
6—8, 10, 11,21, 24—27, 29, and 30 as unpatentable over Fine (US
2008/0317874 Al, published Dec. 25, 2008), Stenzler (US 2006/0207594
Al, published Sept. 21, 2006), McRae (US 6,766,220 B2, issued July 20,
2004), Woolfenden (US 6,564,656 Bl, issued May 20, 2003), Rounbehler
(US 2006/0048779 Al, published Mar. 9, 2006), and Kertzman (US
3,521,865, issued July 28, 1970). Claims 5, 9, 12—20, 22, 23, 28, and 31
have been canceled. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
CLAIMED SUBJECT MATTER
The claimed subject matter relates to a system and a method “of using
liquid nitrogen dioxide (N2O4) with a ventilator to generate and deliver nitric
oxide to a patient.” Spec. 12, Fig. 2. Claims 1 and 21 are independent.
Claim 1 is illustrative of the claimed subject matter and recites:
1. A system for delivering a therapeutic amount of nitric
oxide (NO) comprising:
a ventilator configured to deliver a gas including oxygen
or air;
a liquid reservoir containing dinitrogen tetroxide;
a tube directly connected to the reservoir configured to
release nitrogen dioxide (NO2) gas vaporized from the dinitrogen
tetroxide in the reservoir into the gas to obtain a gas-nitrogen
dioxide mixture including nitrogen dioxide at an amount higher
than a therapeutic amount of nitric oxide, wherein the tube has a
bore diameter size of less than 10 microns, wherein the
therapeutic amount is an amount to be delivered to a patient,
wherein a flow rate from the tube is controlled by a differential
pressure, the bore diameter size and a length of the tube, and
wherein the amount of NO delivered to a patient does not
fluctuate more than 10 ppm between a highest concentration and
a lowest concentration when connected to the ventilator;
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Application 13/017,768
a first receptacle coupled to the tube, wherein the
receptacle comprises an antioxidant capable of converting the
nitrogen dioxide gas into nitric oxide,
a heating element associated with the reservoir to control
a temperature of the reservoir so that only NO2 vapor is
introduced into the oxygen or air flow; and
a patient interface coupled to the first receptacle, wherein
the patient interface is adapted to deliver the therapeutic amount
of nitric oxide.
ANALYSIS
Appellants do not offer arguments in favor of independent claim 21 or
dependent claims 2-4, 6—8, 10, 11, 24—27, 29, and 30 separate from those
presented for independent claim 1. See Br. 5—10. We select claim 1 as the
representative claim, and claims 2—4, 6—8, 10, 11,21, 24—27, 29, and 30
stand or fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
Claim 1 recites “[a] system for delivering a therapeutic amount of
nitric oxide (NO)” “wherein the amount of NO delivered to a patient does
not fluctuate more than 10 ppm between a highest concentration and a
lowest concentration when connected to the ventilator.” Br. 12, Claims App.
Appellants contend that “Stenzler does not meet the first condition to qualify
as analogous art.” Id. at 7. In particular, Appellants contend that
Stenzler is not from the same field of endeavor as the present
invention. The claimed invention relates to a system and a
method for generating a steady flow of [nitric dioxide (NO2)] into
the air system when connected to a ventilator that pulses air into
the lungs (see paragraph [0020]). Paragraph [0032] and FIG. 2
[of the subject invention] disclose that the claimed invention
shows a peak to peak noise of 10 ppm.
Stenzler teaches a device for delivering [nitric oxide (NO)]
to a patient in a pulsed flow, alternating two different
concentrations (i.e. a high concentration and a low concentration)
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Application 13/017,768
of nitric oxide containing gas. See Stenzler, Abstract.
Specifically, Stenzler teaches that the high concentration is
preferably between 160 ppm to 200 ppm, and the low
concentration is preferably between 20 ppm to 40 ppm (see
Stenzler, paragraphs [0026] and [0134]). In other words,
Stenzler teaches away from minimizing the fluctuation between
the high concentration and the low concentration to no more than
10 ppm when a ventilator is connected to a NO delivery system.
Rather, Stenzler teaches that the difference between the high
concentration and the low concentration is preferably as much as
180ppm (= 160 ppm — 20 ppm).
Br. 7-8.
Appellants further contend that “Stenzler also fails to meet the second
condition to quality as analogous art — it is not reasonably pertinent to the
problem faced by the present inventors.” Id. at 8. In particular, Appellants
contend that “Stenzler’s wide fluctuation between the high concentration and
the low concentration of [nitric oxide (NO)] is opposite to the [sic.] solving
the present inventors’ problem of minimizing the fluctuation between the
high concentration and the low concentration.” Id. at 9.
The two separate tests for determining whether a prior art reference is
analogous are: (1) whether the art is from the same field of endeavor,
regardless of the problem addressed; and (2) if the reference is not within the
inventor’s field of endeavor, whether the reference is reasonably pertinent to
the particular problem with which the inventor is involved. In re Bigio, 381
F.3d 1320, 1325 (Fed. Cir. 2004)(citing In re Deminski, 796 F.2d 436, 442
(Fed.Cir.1986) and In re Wood, 599 F.2d 1032, 1036 (CCPA 1979)).
In response Appellants’ first argument, the Examiner correctly points
out that “both Stenzler and Appellants’] invention [are] directed to devices
to deliver nitric oxide in a breathing gas to be inhaled by a patient” and that
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“in an embodiment of Stenzler, a method of delivering a constant
concentration of nitric oxide to a mechanically ventilated patient” is
disclosed in paragraph 31 of Stenzler. See Ans. 13.3 The Examiner properly
reasons that “[bjecause both Stenzler and Appellants’] invention are
directed to systems for delivering a therapeutic amount of [nitric oxide
(NO)] for inhalation by the patient, both Stenzler and Appellants’]
invention are considered to be from the same field of endeavor of the
invention.” Id. In other words, the Examiner finds that Stenzler is within
Appellants’ field of endeavor. Appellants do not provide persuasive
evidence or argument apprising us of error in the Examiner’s findings.
Further, in response to Appellants’ second argument, the Examiner
clarifies that “[t]he primary reference Fine discloses an air pump providing a
flow of gas for inhalation to a patient. Fine does not disclose that the air
pump is a ventilator” and that “Stenzler is relied upon to teach that
ventilators are well-known in the art to provide a breathable gas to a patient
in [nitric oxide (NO)] delivery device (the source of diluent gas can also be a
ventilator, air pump, blower, or other mechanical device that moves
breathable air).” Ans. 14 (citing Stenzler 1133). The Examiner reasons that
it would have been considered obvious to the skilled artisan,
upon seeing Stenzler’s disclosure, to substitute Fine’s air pump
with a ventilator, as the use of a ventilator, air pump, blower, or
other mechanical device are well-known in the art for the purpose
of delivering a medically beneficial amount and sequence of air
to a patient.
3 Dated June 23, 2017.
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Ans. 14. The Examiner’s findings are sound and supported by a
preponderance of the evidence, and the Examiner’s conclusions therefrom
are based on rational underpinnings. Appellants do not provide persuasive
evidence or argument apprising us of Examiner error.
Moreover, Appellants’ arguments are attacks on the references
individually where the Examiner’s rejection is based on the combined
teachings of references. See In re Keller, 642 F.2d 413 (CCPA 1981); In re
Merck & Co., 800 F.2d 1091 (Fed. Cir. 1986)). As clarified by the
Examiner in the Answer, the Examiner relies on Stenzler merely for
disclosing that “ventilators are well-known in the art to provide a breathable
gas to a patient in [nitric oxide (NO)] delivery device (the source of diluent
gas can also be a ventilator, air pump, blower, or other mechanical device
that moves breathable air).” Ans. 14 (citing Stenzler |133). Stated
differently, the Examiner is merely proposing “to substitute Fine’s air pump
with [Stenzler’s] ventilator.” Id. The Examiner relies on Kertzman, not
Stenzler, for disclosing that the amount of nitric oxide (NO) delivered to a
patient does not fluctuate more than 10 ppm between a highest concentration
and a lowest concentration. See Final Act. 7—8, 13—14; see also Ans. 14—16.
Thus, Appellants’ argument that Stenzler fails to disclose that “the
difference between the high concentration and the low concentration” is “no
more than 10 ppm” is unpersuasive. See Br. 8.
Appellants contend that
[i]t is the Examiner’s unfounded speculation that Kertzman can
be applied to provide this teaching. Kertzman teaches a device
for the generation of an accurately known vapor concentration
by permeation, where the device is controlled to produce an
accuracy of ±2-3%. [Appellants] respectfully submit that
“±2~3%” in Kertzman is a relative value that cannot be directly
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compared with an absolute value of “10 ppm” in the claims. For
example, “±2~3%” in Kertzman can be much higher than 10 ppm
if the vapor concentration is higher than 500 ppm. Moreover,
Kertzman’s device is not connected to a ventilator and does not
provide teaching how to maintain the vapor concentration within
10 ppm range when connected to a ventilator.
Br. 9.
As an initial matter, claim 1 recites nothing about “10 ppm” being “an
absolute value.” See Br. 9; see also id. at 12, Claims App.; In re Self, 671
F.2d 1344, 1348 (CCPA 1982) (Limitations not appearing in the claims
cannot be relied upon for patentability). Further, as discussed above, the
Examiner relies on Stenzler for disclosing “a ventilator” and proposes
“substituting] Fine’s air pump with [Stenzler’s] ventilator.” Ans. 14; see
also Final Act. 4. Appellants do not provide persuasive evidence or
argument apprising us of Examiner error. See Br. 6—9.
Here, the Examiner finds that the modified Fine device (i.e., Fine in
view of the teachings of Stenzler, McRae, Woolfenden, and Rounbehler)
“does not disclose the amount of [nitric oxide (NO)] delivered to a patient
does not fluctuate more than 10 ppm between a highest concentration and a
lowest concentration when connecter to a ventilator.” Final Act. 7; see also
id. at 13—14. The Examiner finds that Kertzman discloses a device
“controlled to produce an accuracy of ±2% at a volume of 25 ppm and an
accuracy of ±3% at a volume of 250 to 1500 ppm.” Final Act. 7 (citing
Kertzman 3:14—29); see also id. at 13—14. The Examiner concludes that it
would have been obvious to further modify Fine’s device “by controlling the
diffusion rate so that the amount of [nitric oxide (NO)] delivered to a patient
is within +3% as taught by Kertzman in order to accurately provide a gas of
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a known vapor concentration.” Final Act. 8 (citing Kertzman 1:13—25); see
also id. at 14.
The Examiner states that “[a]s the amount of [nitric oxide (NO)]
delivered to a patient [in Fine] is 40 ppm, the amount delivered fluctuates by
±3%, which would be less than 10 ppm (+1.2 ppm).” Final Act. 8; see also
Ans. 15 (“[W]hen Fine’s device is used at its disclosed operating value, an
accuracy of ±2-3% would be within 10 ppm (+1.2 ppm).”). Based on our
understanding of the Examiner’s findings, the 40 ppm of nitric oxide (NO)
delivered to a patient in Fine represents the mean value and the modified
Fine device, in view of Kertzman’s teachings, would fluctuate between a
highest concentration of 41.2 ppm and a lowest concentration of 38.8 ppm
(i.e., ±1.2 ppm), which is not more than 10 ppm. As such, the Examiner
properly concludes that “the [modified] device of Fine, [as further] modified
with the teaching of Kertzman, when operated according to Fine’s
disclosure, would meet the limitation of not fluctuating more than 10 ppm
between a highest and lowest concentration when connected to a ventilator
(±1.2 ppm).” Ans. 15. Appellants do not provide persuasive evidence or
argument apprising us of Examiner error. See Br. 9—10.
That Stenzler and Kertzman may teach additional structure does not
prevent the Examiner from relying on each reference for limited purposes.
“The test for obviousness is not whether the features of a secondary
reference may be bodily incorporated into the structure of the primary
reference, but rather whether a skilled artisan would have been motivated to
combine the teachings of the prior art references to achieve the claimed
invention.” Allied Erecting & Dismantling Co. v. Genesis Attachments,
LLC, 825 F.3d 1373, 1381 (Fed. Cir. 2016) (internal citations and quotation
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marks omitted). Appellants do not provide persuasive evidence or argument
apprising us of error in the Examiner’s proposed reasoning based upon the
combined teachings of Fine, Stenzler, McRae, Woolfenden, Rounbehler, and
Kertzman. See Br. 6—10.
Appellants contend that “the claim language sufficiently describes
how to enable the claimed invention. The specification discloses that ‘. . .
[t]he heated N2O4 source can leak a precisely controlled amount of NO2 into
the air/oxygen stream that leaves the ventilator.’” Br. 10. (citing Spec. 126).
Appellants conclude that “[t]he Examiner fail[s] to state what other essential
elements to enable the claimed invention are missing in the claims.” Id.
As an initial matter, we note that limitations not appearing in the
claims cannot be relied upon for patentability. See In re Self, 671 F.2d at
1348. There is no recitation in claim 1 of the above cited language from
paragraph 26 of the Specification. We further note that the Examiner does
not propose an enablement rejection of the claims. See Final Act. 2-13.
Upon a thorough review of the record before us, we believe Appellants are
responding to a statement made by the Examiner at page 2 of the Advisory
Action (i.e., “[Appellants do] not recite any additional structure in the claims
that enables [Appellants’] invention to provide a concentration that does not
fluctuate by more than 10 ppm between a highest concentration and a lowest
concentration when connected to a ventilator.”). Based on our
understanding, the Examiner’s position is that Appellants have not recited
“additional structure in the claims” to overcome the Examiner’s proposed
combination based upon the teachings of Fine in view of Stenzler and
Kertzman. See Adv. Act. 2.
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As discussed above, the Examiner relies on Stenzler for disclosing “a
ventilator” and proposes “substituting] Fine’s air pump with [Stenzler’s]
ventilator.” Ans. 14; see also Final Act. 4. Appellants do not provide
persuasive evidence or argument apprising us of Examiner error. See Br. 6—
9. As further discussed above, we agree with the Examiner’s conclusion that
“the [modified] device of Fine, [as further] modified with the teaching of
Kertzman, when operated according to Fine’s disclosure, would meet the
limitation of not fluctuating more than 10 ppm between a highest and lowest
concentration when connected to a ventilator (±1.2 ppm).” Ans. 15.
Appellants do not provide persuasive evidence or argument apprising us of
Examiner error. See Br. 9-10. Appellants further do not apprise us as to
“what other essential elements” to the claimed invention are missing from
the Examiner’s proposed rejection based upon the combined teachings of
Fine, Stenzler, McRae, Woolfenden, Rounbehler, and Kertzman. See Br. 6—
10; see also Final Act. 3—8, 13—14; Adv. Act. 2; Ans. 14—16.
Additionally, in response to Appellants’ argument, the Examiner finds
that
Kertzman discloses a device for generating a known vapor
concentration by which the amount of gas delivered is
determined by the pressure of the gas, the temperature of the
system, the tube wall thickness, and the tube length (Kertzman,
col 2, In 51-60). Kertzman operates in the same manner as
Appellants’] device (by providing precisely controlled amount
of vapor in a gas stream based on the gas pressure, temperature,
and properties of the diffusion tube including its length), and
ventilators are known in the art to provide a flow of air [as
disclosed in Stenzler], therefore, the modified Fine’s device [as
further] modified with the teaching of Kertzman is considered to
provided amount of NO delivered to a patient which does not
fluctuate by more than 10 ppm between a highest concentration
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and a lowest concentration when connected to a ventilator as
recited in claim[] 1.
Ans. 15; see also id. at 13; Final Act. 4, 7—8, 13—14; Adv. Act. 2.
The Examiner’s findings are sound and supported by a preponderance of the
evidence, and the Examiner’s conclusions therefrom are based on rational
underpinnings. Appellants do not provide persuasive evidence or argument
apprising us of Examiner error.
Moreover, to the extent Appellants are arguing that there would be no
reasonable expectation of success in the Examiner’s proposed combination
of the teachings of Fine, Stenzler, McRae, Woolfenden, Rounbehler, and
Kertzman, Appellants have not explained with any specificity why a person
of ordinary skill in the art would not have had an expectation of success in
making the proposed modifications. See Br. 6—10; see also Final Act. 3—8,
13—14; Adv. Act. 2; Ans. 14—16; In re O’Farrell, 853 F.2d 894, 903 (Fed.
Cir. 1988) (noting that all that is required is a reasonable expectation of
success, not absolute predictability of success).
Accordingly, and based on the record presented, we are not persuaded
the Examiner erred in rejecting independent claim 1 as obvious over Fine,
Stenzler, McRae, Woolfenden, Rounbehler, and Kertzman. We sustain the
Examiner’s rejection of claim 1 as obvious over Fine, Stenzler, McRae,
Woolfenden, Rounbehler, and Kertzman. We further sustain the Examiner’s
rejection of claims 2-4, 6—8, 10, 11,21, 24—27, 29, and 30, which fall with
claim 1.
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DECISION
We AFFIRM the decision of the Examiner to reject claims 1—4, 6—8,
10, 11,21, 24—27, 29, and 30 as unpatentable over Fine, Stenzler, McRae,
Woolfenden, Rounbehler, and Kertzman.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
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